Abbott Alinity m System camera generates error with certain tubes
Abbott Molecular is recalling 1,012 Alinity m System units due to a camera detection issue that generates an error message when certain third-party transport medium tubes lack a sample rack retention bar.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with an observed functional issue where the system generates error messages with certain third-party tubes. No reported illnesses, injuries, or hospitalizations are documented, limiting the score to a maximum of 3 per the established rubric.
Plain-English summary
The Alinity m System is a molecular diagnostic device manufactured by Abbott Molecular, Inc. The system's camera detects whether sample tubes are capped. An issue has been identified where the camera may detect a cap on a tube without a retention bar present on the sample rack, causing the system to generate an 'Error - 6013: Has cap, no retention bar' message.
The issue has been specifically observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing (Part Number 3C047N) when used with the Alinity m System. Abbott has indicated that other third-party manufactured tubes could potentially experience the same issue.
Approximately 1,012 units of the Alinity m System (Part Number 08N53-002) have been identified in this recall and distributed worldwide. Abbott Molecular, Inc. is recalling these units to address the camera detection and error message generation issue.
The recalled product
- Product
- Alinity m System, Part Number: 08N53-002
- Manufacturer
- Abbott Molecular, Inc.
- Category
- Medical Device
- Affected units
- 1,012
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: 08N53-002
- UD/DI: 00884999048034. Not Serial Number specific
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Abbott Molecular, Inc.
See all →- HighAbbott Alinity m Resp-4-Plex AMP Kit Multiplex PCR Test Recall
FDA (Devices) · 2025-05-21
- HighAbbott Alinity m Resp-4-Plex Amplification Kit Recall
FDA (Devices) · 2025-05-21
- ModerateAlinity m System nucleic acid testing instruments recalled for liquid spillage
FDA (Devices) · 2025-04-30
- HighAbbott Alinity m HPV test kit control failures from iron contamination
FDA (Devices) · 2024-11-06
- HighAbbott STI and HPV Test Kits Recalled for Quality Control Failures
FDA (Devices) · 2024-11-06
Same hazard · system error
See all →- CriticalSyringe pumps recalled over false motor movement system error messages
FDA (Devices) · 2025-09-10
- HighElectrosurgical generators recalled over system error causing reboots during use
FDA (Devices) · 2025-08-27
- HighLegacy electrosurgical generators recalled over system error triggering repeated device reboots
FDA (Devices) · 2025-08-27
- HighV.A.C. Ulta Therapy Units Recalled Due to Occlusion Sensor Failures
FDA (Devices) · 2024-12-04
- HighOlympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error
FDA (Devices) · 2024-11-06
Similar recalls
- HighAbbott Alinity m System camera firmware installation issue
FDA (Devices) · 2022-01-12
- HighAbbott Alinity m System Molecular Diagnostic Device Amplification Defect Recall
FDA (Devices) · 2022-01-12
- HighAlinity m System recalled for software defect in amplification detection
FDA (Devices) · 2022-01-12
- HighAbbott Alinity m Diagnostic System Recalled for Incorrect Optical Calibration
FDA (Devices) · 2022-08-24
- HighAlinity m System Software Issue Affects Maintenance and Diagnostics Procedures
FDA (Devices) · 2022-01-12
- HighDiagnostic System Software Defects Affecting Sample Processing and Test Accuracy
FDA (Devices) · 2022-11-30